Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis

Active, not recruiting

• Conditions: Acute Pancreatitis (AP); Diabetes Mellitus

• Registration Number: NCT06590935
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

The goal of this observational study is to learn about post-acute pancreatitis diabetes mellitus (PPDM-A). The main questions it aims to answer are:

1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies the same?

2. Are alterations in endocrine and exocrine secretory function in patients with acute pancreatitis associated with all-round outcomes?

All patients with acute pancreatitis have been given the standardized treatment for the condition.

Investigators will compare the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after acute pancreatitis of different etiologies in patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) to explore the association between alterations in endocrine and exocrine secretory function and all-round outcomes.

Detailed Description

Investigators will prospectively collect data from patients with moderately severe (MSAP) and severe acute pancreatitis (SAP) in participant centers.

Study Timeline

• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-10-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female Chinese subjects;
2. Age ≥18 years at the time of signing the informed consent;
3. Patients with a complete diagnosis of MSAP and SAP (according to the Chinese guidelines for the diagnosis and treatment of acute pancreatitis 2019);
4. Voluntary signatories of informed consent

Exclusion Criteria

1. Patients with a history of diabetes mellitus or pre-diabetes mellitus, or glycosylated hemoglobin ≥ 6.0% or venous FPG ≥ 6.1 mmol/L at admission;
2. Patients have any evidence of type 1 diabetes-related autoimmunity;
3. Patients have any risk for secondary diabetes due to exposure to medications or other endocrine diseases;
4. Combined with pancreas-related trauma or a history of pancreatic surgery;
5. Patients undergo pancreatic surgery during treatment;
6. Pregnancy or breastfeeding;
7. Patients suffer from severe cardiac, hepatic or renal insufficiency or malignant diseases;
8. Failure to sign informed consent due to cognitive impairment or other conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who developed glucose metabolic disorders (pre-diabetes and diabetes mellitus)	From the AP treatment to 5 years after the end of treatment	The diagnosis of glucose metabolic disorders should be made applying the criteria of the American Diabetes Association.

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China